NCT06685250尚未招募不适用
Randomized Controlled Trial Comparing Low (8 MmHg) Vs. Standard (14 MmHg) CO2 Insufflation Pressure on Postoperative Pain in Patients Undergoing Laparoscopic Cholecystectomy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 190
- 主要终点
- Postoperative pain
研究概览
简要总结
Randomized Controlled Trial to compare the effect of low (8 mmHg) versus Standard (14 mmHg) insufflation pressure of CO2 pneumoperitoneum on postoperative pain in patients undergoing laparoscopic cholecystectomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA 1 or ASA 2
- •uncomplicated symptomatic gallblader lithiasis scheduled for elective surgery
- •no choledocholithiasis
- •no associated surgical procedures
- •no cerebrovasculare accident with neurological sequelae or other neurological disorders that affects sensation of pain
- •no ascites
- •no carcinomatosis
排除标准
- •conversion to laparotomy
- •need to keep an escat drain
研究组 & 干预措施
Pressure 8 mmHg
Experimental
干预措施: Laparoscopic cholecystectomy (Procedure)
Pressure 14 mmHg
Active Comparator
干预措施: Laparoscopic cholecystectomy (Procedure)
结局指标
主要结局
Postoperative pain
时间窗: Hour 6
Visual Analog Scale (VAS) .from 0 to 10 0 no pain, 5 moderate pain, 10 worst possible pain
次要结局
- postoperative pain(Hour 12)
- Postoperative pain(Hour 24)
- vommiting (PONV score)(from 0 to 24 hours after surgery)
- morbidity(30 days)
- postoperative length of stay(30 days)
研究者
Dr Amine BEN SAFTA
surgical fellow in General Surgery
Hopital Charles Nicolle
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